Duopa (AbbVie) – Failed Stability Test (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07
Brand
AbbVie Inc.
Lot Codes / Batch Numbers
Lots: 1055692, Expiration Date (Frozen) 06/01/2018 1057881, Expiration Date (Frozen) 06/02/2018 1060138, Expiration Date (Frozen) 06/13/2018 1060140, Expiration Date (Frozen) 06/15/2018 1061258, Expiration Date (Frozen) 06/17/2018 1061262, Expiration Date (Frozen) 06/30/2018 1063033, Expiration Date (Frozen) 07/14/2018
Products Sold
Lots: 1055692, Expiration Date (Frozen) 06/01/2018 1057881, Expiration Date (Frozen) 06/02/2018 1060138, Expiration Date (Frozen) 06/13/2018 1060140, Expiration Date (Frozen) 06/15/2018 1061258, Expiration Date (Frozen) 06/17/2018 1061262, Expiration Date (Frozen) 06/30/2018 1063033, Expiration Date (Frozen) 07/14/2018
AbbVie Inc. is recalling Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassette due to Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug m. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, TN
Page updated: Jan 7, 2026